Effects of intraarticular IL1-Ra on pain and inflammatory mediators after knee arthroscopy –a double blind, placebo controlled study using microdialysis technique

INTERVENTION: Trade Name: Kineret Product Name: Kineret Product Code: EMEA/H/C/000363 Pharmaceutical Form: Injection Pharmaceutical form of the placebo: Injection Route of administration of the placebo: Intraarticular use CONDITION: Post operative pain after diagnostic or therapeutic knee arthroscopy ; MedDRA version: 16.0 Level: HLGT Classification code 10023213 Term: Joint disorders System Organ Class: 10028395 ‐ Musculoskeletal and connective tissue disorders Therapeutic area: Diseases [C] ‐ Musculoskeletal Diseases [C05] PRIMARY OUTCOME: Main Objective: To examine the postoperative pain relieving effects of anakinra compared to placebo Primary end point(s): Pain is measured postoperatively using the verbal rating scale (VRS 0‐4). Patients with VRS 2 or 3 are included in the intervention group receiving either active drug or placebo. Pain is then scored on the visual analogue scale (VAS) every 20 minutes during the first two postoperative hours. Secondary Objective: Biomarkers of inflammation and pain Timepoint(s) of evaluation of this end point: Pain is measured as soon as possible postoperatively using the verbal rating scale (VRS 0‐4). Pain is then scored on the visual analogue scale (VAS) every 20 minutes during the first two postoperative hours. SECONDARY OUTCOME: Secondary end point(s): The use of morphine is registered throughout the observation period Timepoint(s) of evaluation of this end point: 2 hours postoperatively INCLUSION CRITERIA: Otherwise healthy patients between 18 and 70 years undergoing diagnostic or therapeutic knee arthroscopy. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15